- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02175862
Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.
In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus Hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design.
Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation.
The present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. Patients were followed until may 1st, 2014.
Primary outcome is early retirement and secondary outcomes are quality of life and mortality.
The investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Copenhagen, Danmark, 2100
- Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients treated by a trauma team in the catchment area of PS-HEMS.
For all labor market attachment analysis the investigators only include patients between 18 to 60 years of age. For all other analysis (mortality and quality of life) there are no age limits.
Exclusion Criteria:
- Patients transported by private means or by the police.
- Patients who at the emergency department were categorized as non-trauma patients.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Trauma patients before PS-HEMS
The "before" period was between december 1 2009 to april 30 2010 (five months).
|
|
Traume patients after PS-HEMS
The "after" period was between may 1 2010 to april 30 2011 (12 months).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Labor market attachment
Tidsramme: 3 - 4.5 years after trauma
|
Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability
|
3 - 4.5 years after trauma
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Health-related quality of life
Tidsramme: 3 - 4.5 years after trauma
|
Health-related quality of life is measured using the Danish version of the Short Form 36 (SF-36) questionaire.
|
3 - 4.5 years after trauma
|
|
All cause mortality
Tidsramme: 3 - 4.5 years after trauma
|
Primary analysis: Risk of death.
Secondary analysis: Predictors of death
|
3 - 4.5 years after trauma
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Kamilia S. Funder, MD, Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet
- Studieleder: Jacob Steinmetz, MD, PhD, Trauma Center, Copenhagen University Hospital, Rigshospitalet
Publikationer og nyttige links
Generelle publikationer
- Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
- Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol. 1998 Nov;51(11):1001-11. doi: 10.1016/s0895-4356(98)00092-4.
- Kuhlman MB, Lohse N, Sorensen AM, Larsen CF, Christensen KB, Steinmetz J. Impact of the severity of trauma on early retirement. Injury. 2014 Mar;45(3):618-23. doi: 10.1016/j.injury.2013.09.007. Epub 2013 Sep 16.
- Hesselfeldt R, Steinmetz J, Jans H, Jacobsson ML, Andersen DL, Buggeskov K, Kowalski M, Praest M, Ollgaard L, Hoiby P, Rasmussen LS. Impact of a physician-staffed helicopter on a regional trauma system: a prospective, controlled, observational study. Acta Anaesthesiol Scand. 2013 May;57(5):660-8. doi: 10.1111/aas.12052. Epub 2013 Jan 7.
- Overgaard M, Hoyer CB, Christensen EF. Long-term survival and health-related quality of life 6 to 9 years after trauma. J Trauma. 2011 Aug;71(2):435-41. doi: 10.1097/TA.0b013e31820e7ec3.
- Ringburg AN, Polinder S, Meulman TJ, Steyerberg EW, van Lieshout EM, Patka P, van Beeck EF, Schipper IB. Cost-effectiveness and quality-of-life analysis of physician-staffed helicopter emergency medical services. Br J Surg. 2009 Nov;96(11):1365-70. doi: 10.1002/bjs.6720.
- MacKenzie EJ, Shapiro S, Smith RT, Siegel JH, Moody M, Pitt A. Factors influencing return to work following hospitalization for traumatic injury. Am J Public Health. 1987 Mar;77(3):329-34. doi: 10.2105/ajph.77.3.329.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALH1-KF-2014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .